CDSCO Manufacturing License for Ultrasonic respiratory humidifier

Introduction

The Central Drugs Standard Control Organization (CDSCO) is the crux of the Indian pharmaceuticals sector and a principal body that manages the safety, efficacy, and quality of medicinal products retailed in India. While this encapsulates pharmaceutical drugs, it uniquely implicates the thriving medical device industry.

Undeniably, manufacturing licenses represent the heart of the medical device industry, acting as gatekeepers of quality, safety, and product ethics. One such device which holds a prominent role in the healthcare sector is the Ultrasonic Respiratory Humidifier. The rest of this post dives into the essentials of this medical device and the vital role the CDSCO plays with it.

Explore more about CDSCO's jurisdiction at CDSCO's portal

• What is Ultrasonic Respiratory Humidifier?
• The Role of CDSCO in Medical Device Regulation
• How to manufacture Ultrasonic Respiratory Humidifier
• Fees for manufacturing license for Ultrasonic Respiratory Humidifier
• Why is a Manufacturing License Necessary for Ultrasonic Respiratory Humidifier?
• Steps to Obtain a CDSCO Manufacturing License for Ultrasonic Respiratory Humidifier
• Frequently Asked Questions (FAQs)
• Conclusion

What is Ultrasonic Respiratory Humidifier?

An Ultrasonic Respiratory Humidifier is a specialized device engineered to transform water into micro-particles using ultrasound. This enhanced moisture enriches the air or gases channeled to a patient via a breathing tube or circuit. These medical devices lend a hand during anesthesia, contributing heavily towards maintaining a patient's requisite humidity throughout the procedure.

The Role of CDSCO in Medical Device Regulation

The Central Drugs Standard Control Organization (CDSCO), is bestowed with the noble task of safeguarding and enhancing public health by ensuring the quality, safety, and effectiveness of drugs, cosmetics, and medical devices. Their mission is to regulate medical devices and nurture excellence within the industry, establishing trust with consumers and practitioners.

How to manufacture Ultrasonic Respiratory Humidifier

The manufacturing of an Ultrasonic Respiratory Humidifier calls for legal licensure. As this device falls under risk class B, manufacturers are required to secure an MD5 license.

Fees for manufacturing license for Ultrasonic Respiratory Humidifier

Acquiring an MD5 manufacturing license necessitates fees totaling up to Rs. 5,000 for the license and an additional Rs. 500 for each model of the device.

Why is a Manufacturing License Necessary for Ultrasonic Respiratory Humidifier?

Procuring a manufacturing license for the Ultrasonic Respiratory Humidifier, or any other medical device, is mandatory. This measure assures quality and safety in the production of medical devices, guards patients from the risk of substandard products, and invariably establishes regulatory compliance within the healthcare sector.

Steps to Obtain a CDSCO Manufacturing License for Ultrasonic Respiratory Humidifier

To secure a manufacturing license, applicants should prepare:

• A Device Master File
• Quality Management Certificate
• Detailed Device Information
• Site related documents etc.

The application procedure consists of:

1. Submission of required documents and application
2. Evaluation and inspection of premises
3. Approval or rejection of the application
4. Grant of license upon approval

For more information on obtaining an MD5 license, head over to our detailed guide here.

Frequently Asked Questions (FAQs)

1. What is the risk class of Ultrasonic Respiratory Humidifier as per Medical Device Rules, 2017? Ultrasonic Respiratory Humidifier is classified under risk class B.

2. What license is needed to manufacture Ultrasonic Respiratory Humidifier? An MD5 license is required to manufacture Ultrasonic Respiratory Humidifier.

3. What is the fee for an MD5 license for Ultrasonic Respiratory Humidifier? The license fee for an MD5 license is Rs. 5,000 and Rs. 500 per product.

4. Who will issue the manufacturing license for Ultrasonic Respiratory Humidifier? The state FDA will issue the license.

5. Is repackaging of Ultrasonic Respiratory Humidifier considered manufacturing? Yes, repackaging of Ultrasonic Respiratory Humidifier is considered manufacturing requiring an MD5 license.

Conclusion

Remember, the quest to procure a manufacturing license doesn't have to be a daunting experience. Reach out to us at Pharmadocx Consultants for personalized guidance through this process. Alternatively, you can call us at +91-7404557227, or simply drop us an email at [email protected]. Together, let's commit to quality, safety, and compliance in the medical device industry.